Family Connections

Family Connections: Structured Family Deliberation for Decisions About Home Ventilation

This study seeks to evaluate a Structured Family Deliberation that will serve as the primary intervention in a multicenter controlled trial involving families considering tracheostomy and home ventilation for the child. In this study, the investigators will evaluate the feasibility, usefulness, face validity, and preliminary impact of this approach on preparedness for decision making among participants.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Respiratory Failure
• Intervention / Treatment: Other: Structured Family Deliberation

Detailed Description

The investigators will recruit 10 intervention families and 5 control families who are currently admitted to the neonatal or pediatric intensive unit and whose physician anticipates a decision about home ventilation within the next 30 days. Intervention families will receive the Structured Family Deliberation, which includes a guided review of a web-based decisional aid. Control families will receive a link to the website for independent review. All families will be assessed at 1 month with a survey assessing preparedness for decision-making, parental stress and coping, and a qualitative interview.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parents/legal guardians of children admitted to the neonatal or pediatric intensive care unit and whose physician anticipates a decision about home ventilation within the next month.

Exclusion Criteria:

• Parents will be excluded if:
• their child is in foster care or state guardianship
• they are unable to understand the purpose of the study
• they cannot reasonably participate in study demands
• are not fluent in English (the web-based decisional aid is not yet available in other languages).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention families will participate in the Structured Family Deliberation that includes a clinician-led review of a web-based decisional aid.	Other: Structured Family Deliberation; Intervention families will be guided through the six modules included in the web-based decisional aid using a Structured Family Deliberation Tool. Parents will view narrated videos corresponding to each module and will be asked a series of questions related to their own lives and values. The process will continue until all modules are reviewed and all questions are completed.
No Intervention: Control; Control families will undergo the standard decisional process for home ventilation and will also review the web-based decisional aid independently.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as assessed by proportion of families enrolled	Feasibility will be measured by the proportion of families approached that are successfully enrolled.	Duration of study period (12 months)
Feasibility as assessed by time spent engaging with the website by parents	Feasibility will be measured by time parents spend engaging with the website.	Assessed at 30 day follow-up interview
Feasibility as assessed by proportion of successfully completed interventions	Feasibility will be measured by success completing the intervention by the study team	Duration of study period (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions	Qualitative interviews will be used to determine whether participants perceived either process as useful.	Assessed at 30 day follow-up interview
Preparedness in decision making as assessed by Preparation for Decision-Making Scale	Preparation for decision-making will be assessed using a validated survey (Preparation for Decision-Making Scale). Scores range from 10-50; A higher score on the Preparation for Decision-Making scale indicates greater preparedness.	Assessed at 30 day follow-up interview
Factors in decision making as assessed by participants responses to qualitative interview questions	Preparation for decision-making will be assessed by a qualitative interview with each family.	Assessed at 30 day follow-up interview
Parental stress and coping as assessed by participants responses to qualitative interview	Parental stress and coping will be assessed assessed by a qualitative interview with each family.	Assessed at 30 day follow-up interview

Collaborators and Investigators

• Sponsor: Johns Hopkins All Children's Hospital
• Investigators: Principal Investigator: Nicholas A Jabre, MD, Johns Hopkins All Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Qualitative research; Tracheostomy; Home mechanical ventilation; Children with medical complexity; Medical ethics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: IRB00323418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No